endosulfan (Thiodan) Availability of Risk Assessments 6/01
ENVIRONMENTAL PROTECTION AGENCY
Endosulfan Pesticides; Availability of Risk Assessments
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: This notice announces the availability of risk assessments
that were developed as part of EPA's process for making pesticide
Reregistration Eligibility Decisions (REDs) and tolerance reassessments
consistent with the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA). These risk
assessments are the human health and ecological risk assessments and
related documents for endosulfan. This notice also starts a 60-day
public comment period for the risk assessments and risk management
strategies. By allowing access and opportunity for comment on the risk
assessments, EPA is seeking to strengthen stakeholder involvement and
help ensure decisions made under FQPA are transparent and based on the
best available information. The tolerance reassessment process will
ensure that the United States continues to have the safest and most
abundant food supply.
DATES: Comments, identified by the docket control number OPP-34242 for
endosulfan, must be received on or before November 13, 2001.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit II. of the SUPPLEMENTARY INFORMATION. To ensure proper
receipt by EPA, it is imperative that you identify the docket control
number OPP-34242 for endosulfan in the subject line on the first page
of your response.
FOR FURTHER INFORMATION CONTACT: Stacey Milan, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-2505; e-mail address:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, nevertheless, a
wide range of stakeholders will be interested in obtaining the risk
assessments for endosulfan, including environmental, human health, and
agricultural advocates; the chemical industry; pesticide users; and
members of the public interested in the use of pesticides on food.
Since other entities also may be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions regarding the applicability of
this action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
On the Home Page select ``Laws and Regulations'', ``Regulations and
Proposed Rules,'' and then look up the entry for this document under
the Federal Register--Environmental Documents.'' You can also go
directly to the Federal Register listings at http://www.epa.gov/
fedrgstr/. In addition, copies of the pesticide risk assessments
released to the public may also be accessed at http://www.epa.gov/
2.In person. The Agency has established an official record for this
action under docket control numbers OPP-34242. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed,paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. How Can I Respond to this Action?
A. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number for the specific chemical of
interest in the subject line on the first page of your response.
1. By mail. Submit comments to: Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver comments to: Public Information
and Records Integrity Branch, Information Resources and Services
Division, Office of Pesticide Programs, Environmental Protection
Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington,
VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
3. Electronically. Submit electronic comments by e-mail to: opp-
firstname.lastname@example.org or you can submit a computer disk as described in this
unit. Do not submit any information electronically that you consider to
be CBI. Electronic comments must be submitted as an ASCII file,
avoiding the use of special characters and any form of encryption.
Comments and data will also be accepted on standard computer disks in
WordPerfect 6.1/8.0/9.0 or ASCII file format. All comments in
electronic form must be identified by the docket control number of the
chemical of specific interest. Electronic comments may also be filed
online at many Federal Depository Libraries.
B. How Should I Handle CBI Information that I Want to Submit to the
Do not submit any information electronically that you consider to
CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person listed under FOR FURTHER INFORMATION CONTACT.
III. What Action is the Agency Taking?
EPA is making available to the public the risk assessments that
have been developed as part of the Agency's interim public
participation process for tolerance reassessment and reregistration.
During the next 60 days, EPA will accept comments on the human health
and ecological risk assessments and other related documents for
endosulfan, available in the individual pesticide docket. Like other
REDs for pesticides developed under the interim process, the Endosulfan
RED will be made available for public comment.
EPA and USDA have been using a pilot public participation process
for the assessment of organophosphate pesticides since August 1998. In
considering how to accomplish the movement from the current pilot being
used for the organophosphate pesticides to the public participation
process that will be used in the future for non-organophosphates, such
as endosulfan, EPA and USDA have adopted an interim public
participation process. EPA is using this interim process in reviewing
the non-organophosphate pesticides scheduled to complete tolerance
reassessment and reregistration in 2001 and 2002. The interim public
participation process ensures public access to the Agency's risk
assessments while also allowing EPA to meet its reregistration
commitments. It takes into account that the risk assessment development
work on these pesticides is substantially complete. The interim public
participation process involves: A registrant error correction period; a
period for the Agency to respond to the registrant's error correction
comments; the release of the refined risk assessments and risk
characterizations to the public via the docket and EPA's internet
website; a significant effort on stakeholder consultations, such as
meetings and conference calls; and the issuance of the risk management
decision document (i.e., RED) after the consideration of issues and
discussions with stakeholders. USDA plans to hold meetings and
conference calls with the public (i.e., interested stakeholders such as
growers, USDA Cooperative Extension Offices, commodity groups, and
other Federal government agencies) to discuss any identified risks and
solicit input on risk management strategies. EPA will participate in
USDA's meetings and conference calls with the public. This feedback
will be used to complete the risk management decisions and the RED. EPA
plans to conduct a close-out conference call with interested
stakeholders to describe the regulatory decisions presented in the RED.
REDs for pesticides developed under the interim process will be made
available for public comment.
Included in the public version of the official record are the
Agency's risk assessments and related documents for endosulfan. As
additional comments, reviews, and risk assessment modifications become
available, these will also be docketed. The endosulfan risk assessments
reflect only the work and analysis conducted as of the time they were
produced and it is appropriate that, as new information becomes
available and/or additional analyses are performed, the conclusions
they contain may change.
List of Subjects
Environmental protection, Chemicals, Pesticides and pests.
Dated: June 22, 2001.
Director, Special Review and Reregistration Division, Office of
[FR Doc. 01-23002 Filed 9-12-01; 8:45 am]
BILLING CODE 6560-50-S